CN113194808A

CN113194808A - Ear visualization and processing system

Info

Publication number: CN113194808A
Application number: CN201980084446.8A
Authority: CN
Inventors: 吾德·班多瑞; 伊兰·班多瑞
Original assignee: 3NT Medical Ltd
Current assignee: 3NT Medical Ltd
Priority date: 2018-12-18
Filing date: 2019-12-13
Publication date: 2021-07-30
Anticipated expiration: 2039-12-13
Also published as: EP3897341A1; CN113194808B; US20240023787A1; JP7401547B2; US11723519B2; US20200187760A1; US10492670B1; US20220095900A1; US12022999B2; JP2022514323A; US11202557B2; WO2020128610A1

Abstract

An apparatus for visualizing and providing suction for surgery in the ear may comprise: a handle; a spindle extending from the handle; an imaging sensor at a distal end of the main shaft; a light source at a distal end of the spindle; a suction shaft extending from the handle. The device may further include a spring coupled with the aspiration shaft and/or the handle such that the aspiration shaft automatically retracts when the aspiration shaft is advanced in the distal direction and then released. The suction shaft may have a curved distal portion and the device may have a thumb press that allows the user to rotate the suction shaft to suction in different directions. Some embodiments may include a suction shaft having a sharpened distal tip configured for placement of an ear tube in the tympanic membrane.

Description

Ear visualization and processing system

Cross Reference to Related Applications

This application is filed as a PCT international patent application on 12/13/2019 and claims priority from U.S. provisional patent application No.62/781,035 filed on 18/12/2018, U.S. patent application No.16/413,310 filed on 15/5/2019, and U.S. patent application No.16/698,074 filed on 27/11/2019, the disclosures of which are incorporated herein by reference in their entireties.

Background

There are many different reasons for performing middle ear surgery on patients, the most common being chronic recurrent ear infections. When performing middle ear surgery, an otorhinolaryngology (ENT) surgeon (or "otorhinolaryngologist") typically visualizes the middle ear and the surgery in one of two ways. In some cases, the surgeon will use a microscope positioned in front of the surgeon's eye, and she will typically hold the suction device with her own non-dominant/dominant hand and the surgical tool with the dominant/dominant hand. In other cases, the surgeon uses a handheld endoscope to visualize the middle ear. The use of hand-held endoscopes is problematic in several different ways.

First, standard endoscopes have long shafts and are not manufactured for use in the ear. When an ENT surgeon uses an endoscope in the ear, he must hold the handle of the endoscope in midair above the patient's head, with the surgeon's hand suspended in midair and unsupported. This factor alone is problematic because if the surgeon inadvertently moves his unsupported hand during the procedure, he will easily move the distal end of the endoscope, which may damage one or more of the delicate structures of the tympanic membrane or middle ear.

Second, in combination with the first problem, endoscopes are typically much heavier than the small and thin surgical tools used in middle ear surgery. Thus, a surgeon may have an ergonomic imbalance between a relatively heavy endoscope in its non-dominant/dominant hand and a relatively light surgical device in its dominant/dominant hand. This imbalance increases the difficulty of stabilizing the endoscope. Furthermore, suspending a heavy endoscope above a patient's head during surgery can quickly cause fatigue in the surgeon's arms and hands.

Third, since the surgeon holds the endoscope in one hand, that hand is no longer free to hold the suction device or surgical tool. Thus, when an endoscope is used for visualization, the surgeon cannot use the suction device and visualize the inside of the ear at the same time.

Fourth, standard endoscopes have a straight shaft, so the surgeon must hold the endoscope in a line back from the patient's ear. Since the position of the endoscope is directly in the visual path of the microscope, the positioning of this straight line makes it impossible or at least very challenging to use the endoscope and the microscope in the same surgical procedure. This is a disadvantage because in some procedures, it is desirable for the ENT surgeon to be able to switch back and forth quickly and easily between viewing with a microscope and viewing with an endoscope. It is also challenging for the surgeon to manipulate multiple tools with straight axes held in both hands during ear surgery because the hands must be held close together (due to the small diameter of the ear canal) and when the surgeon manipulates these tools to perform the surgery, they tend to collide with each other.

For at least these reasons, it would be advantageous to have an improved system and method for ear visualization. Ideally, such systems and methods would be easy to use, allow good visualization of the ear, and be compatible with the use of other ear surgical devices. At least some of these objectives will be achieved in the present disclosure.

Disclosure of Invention

The present disclosure describes different embodiments of an otoendoscopic device, system, and method for visualizing an ear surgery. In some embodiments, an otoendoscopic device comprises: a handle; a visualization spindle that holds a visualization component (e.g., a camera); and a tool attachment mechanism for coupling the surgical tool with the otoscope. Some embodiments also include the surgical tool itself. In particular, several embodiments include a visualization component and a suction component that work together as one device. The suction component (or other tool in alternative embodiments) may be coupled with the visualization component in a number of different ways, such as through a sheath, through one or more tubes or lumens, through a visualization spindle, and so forth.

The device is configured to be held in and operated with one hand, and is short and thin enough to be easily advanced into the ear canal, and allows the surgeon to rest her hand on the patient's head while holding the device during ear surgery, which the surgeon would normally do with his hand holding the tool in ear surgery for stability. In various embodiments, the camera may be free to roll (or "turn") about its own axis within the sheath, the camera may be free to rotate about the longitudinal axis of the aspiration device within the sheath, and/or the attached aspiration device or other surgical tool may be free to rotate about the camera and/or about its own axis.

In one aspect of the present disclosure, an apparatus for visualizing and providing suction for surgery in an ear may comprise: a handle; a spindle extending from the handle and defining a longitudinal axis; an imaging sensor at a distal end of the spindle; a light source at the distal end of the spindle; a suction shaft extending from the handle and parallel to the longitudinal axis of the main shaft; and a spring coupled with the suction shaft and/or the handle such that when the suction shaft is advanced in a distal direction and then released, the suction shaft automatically retracts. Some embodiments may further comprise a thumb press member coupled with the proximal end of the suction shaft, wherein the spring is disposed on the proximal portion of the suction shaft between the top of the handle and the bottom of the thumb press member.

In some embodiments, the suction shaft comprises: a straight proximal portion extending parallel to a longitudinal axis of the main shaft; and a curved distal portion, wherein the suction shaft is coupled to the handle such that the suction shaft can be rotated and thereby direct the curved distal portion in different directions. Such embodiments may further include a thumb press member coupled to the proximal end of the suction shaft. Optionally, surface features may be included on a top surface of the thumb pressing member to assist a user in rotating the thumb pressing member to rotate the suction shaft. In some embodiments, the apparatus may further comprise: a handle suction port on the handle; a freely rotating suction member disposed on a proximal portion of the suction shaft such that the freely rotating suction member does not rotate when the suction shaft rotates; a suction shaft suction port on the freely rotating suction member; and a suction tube connecting the handle suction port with the suction shaft suction port. In some embodiments, the freely rotating suction member houses two O-rings positioned above and below a bore in the suction shaft, the bore communicating with the suction shaft suction port on the freely rotating suction member, and the O-rings and the freely rotating suction member forming a seal with the suction shaft over the bore.

In various embodiments, the suction shaft has an outer diameter of no greater than 1.1 millimeters. Some embodiments further comprise a suction shaft guide positioned on one side of the main shaft, wherein the suction shaft extends through the suction shaft guide. In some embodiments, the apparatus comprises: a first suction shaft guide positioned on a first side of the main shaft, and a second suction shaft guide positioned on a second side of the main shaft, wherein the suction shaft is passable through the first suction shaft guide or the second suction shaft guide to provide suction on either side of the main shaft.

In some embodiments, the suction shaft includes a sharp distal tip for piercing the tympanic membrane, and the device further includes a stop member on the suction shaft for preventing an ear tube positioned on the suction shaft from sliding proximally along the suction shaft past the stop member. In some embodiments, the handle is adjustable from a straight configuration to an angled configuration. Other embodiments may include a handle angle adjustment member removably attached to the handle to adjust the angle at which the user holds the handle.

In some embodiments, the suction shaft extends alongside the main shaft. Alternatively, the suction shaft may extend through the main shaft. The handle includes at least one suction tube port for attaching a suction tube between the handle and the suction shaft. The handle further includes at least one suction finger control port configured to allow a user to control the application of suction by placing a finger on the finger control port and releasing the finger from the finger control port. Additionally, the handle includes a finger loop configured to allow the device to be held by a single finger of a user. In one embodiment, the finger ring is configured to extend around a middle finger of one hand of the user, the device further comprises a thumb-pressing member to be manipulated by a thumb of the same hand, and the handle further comprises a suction control port configured to be covered by an index finger of the same hand.

In another aspect of the present disclosure, an apparatus for visualizing a surgical procedure on an ear may include: a suction tube; a camera coupled with the suction tube in a side-by-side arrangement; and a sheath disposed around an outside of the suction tube and an outside of the camera to couple the suction tube and the camera together. In some embodiments, the sheath holds the camera and aspiration tube as follows: the camera is free to roll or rotate within the sheath about its own axis, and the camera is also free to rotate within the sheath about the longitudinal axis of the suction tube. In some embodiments, the aspiration tube may have an outer diameter of no more than about 1.1 millimeters, and the camera may have an outer diameter of no more than about 2.5 millimeters. In some embodiments, for example, the sheath is disposed around, but not fixedly attached to, either of the camera and the suction tube, so that the camera and the suction tube roll and rotate freely within the sheath. For example, the surgeon may want to roll the camera for image orientation, as when moving the device from one hand to the other, and/or may want to rotate the camera around the suction tube for ergonomic reasons.

In some embodiments, the suction tube is rigid and comprises: a tubular portion having a distal suction end, a suction device attachment end opposite the distal suction end, and a bend in the tubular portion. In some embodiments, for example, the tubular portion is located about 40-100 millimeters from the distal suction end. In one embodiment, the bend in the tubular portion forms an angle of about 45 degrees, although other angles are possible in alternative embodiments. In some embodiments, the sheath is shorter than the distance from the distal suction end to the bend in the tubular portion, and the camera and sheath are configured to slide along the tubular portion of the suction tube from a first position in which the distal end of the camera is adjacent the distal suction end of the tubular portion and a second position in which the distal end of the camera is proximate the distal suction end. In some embodiments, the suction tube is made of metal. In some embodiments, at least a portion of the camera may be flexible. In some embodiments, the jacket is made of a heat shrinkable polymer.

In another aspect of the present disclosure, a method for performing a surgical procedure on a patient's ear includes: the combined visualization and aspiration device is held in one hand and its distal end is advanced into the ear. The combined visualization and aspiration device may be the same as or similar to the device described immediately above, and may have any or all of the features described above. The method further comprises the following steps: using a camera to view the interior of the ear; activating a suction tube inside the ear; and performing a surgical procedure on the ear using a surgical tool held by a hand that does not hold the combined visualization and aspiration device. The method may further comprise: one or more structures within the ear are held and moved using the activated suction tube of the device. The activated suction tube may alternatively or additionally be used to suck fluid from the ear.

In some embodiments, the method may further comprise: the camera is rolled within the sheath about its own longitudinal axis. The method may further comprise: the camera is rotated within the sheath about the longitudinal axis of the suction tube. In some embodiments, the method may comprise: the ears were additionally observed using a microscope. Optionally, the suction tube may include a bend, and the method may further comprise: maintaining the combined visualization and aspiration device out of direct line of sight between the ear and the surgeon's eye. The method may further comprise: supporting a hand holding the combined visualization and suction device on a patient's head during a surgical procedure. Optionally, the method may comprise: the hand holding the surgical tool is supported on the patient's head during the surgical procedure.

In another aspect of the present disclosure, an apparatus for visualizing a surgical procedure in an ear can include an ear endoscope and a coupler. The ear endoscope includes: a handle; a shaft extending from the handle and having a bend with an angle of 90-155 degrees, an outer diameter of no more than 2.5 millimeters, and a length of 30-80 millimeters; an imaging sensor at a distal end of the shaft; and a light source. A coupler is attached to one side of the otoscope shaft for attaching a tool to an endoscope. In various embodiments, the surgical tool and the overall device may include any of the features described above. The surgical tool may be a suction device as previously described, or alternatively, the surgical tool may be any other suitable tool, such as, but not limited to: cutting devices, piercing devices, ear tube placement devices, introducers, forceps, or pliers.

In another aspect of the present disclosure, a method for performing a surgical procedure in an ear of a patient may first comprise: attaching a tool to an ear endoscope in a side-by-side arrangement using a coupler, wherein the ear endoscope comprises a shaft having a bend and an outer diameter of no more than 2.5 millimeters. The method may further comprise: holding a handle of the ear endoscope in one hand; advancing a distal end of the otoscope into the ear with an attached tool; viewing the interior of the ear; using the ear endoscope; and using a tool attached to the otoscope to assist or perform at least a portion of the surgical procedure. The combined visualization and surgical tool apparatus may be the same as or similar to the embodiments described above, and may include any of the features described above.

In another aspect of the present disclosure, an ear endoscopic device for use in surgery in an ear may include: a handle; a visualization shaft extending from the handle; a tool guide extending from the handle and parallel to the visualization shaft, and configured to guide a tool into an ear with the visualization shaft; an imaging sensor located at a distal end of the visualization shaft; and a light source. In one embodiment, the otoendoscopic device may comprise: at least one tool coupling on one side of the shaft; at least one suction shaft insertion port at or near a distal end of the handle; two side suction tube connection ports at or near a distal end of the handle; a rear suction tube connection port at or near a proximal end of the handle; and a suction lumen connecting the rear suction tube connection port to the two side suction tube connection ports. In various embodiments, the shaft and handle may form an angle between about 90 degrees and about 155 degrees. In some embodiments, the shaft may have an outer diameter of no more than about 2.5 millimeters and a length between about 30 millimeters and about 80 millimeters.

In some embodiments, the otoscope further comprises a suction device. The suction device may include: a suction shaft for insertion through the at least one suction shaft insertion port and the at least one tool coupling; a thumb-depressing member coupled with the suction shaft to allow a user to advance the suction shaft; a side suction tube for attaching the suction shaft to one of the two side suction tube connection ports through the thumb press; and a rear suction tube for connecting the rear suction tube connection port to a suction source. The suction device may further include a spring disposed on a proximal portion of the suction shaft between the thumb press member and a handle of the ear endoscope. The spring may be configured to: automatically retracting the suction shaft relative to the shaft when the thumb press is released. In some embodiments, one of the two side suction tube connection ports that is open, and not attached to a side suction tube, is configured to act as a finger-operated suction controller for controlling the application of suction force by a user's finger.

In some embodiments, the handle comprises two tool couplers arranged on opposite sides of the shaft and two suction shaft insertion ports, wherein each of the two suction shaft insertion ports feeds into a respective one of the two tool couplers. In some embodiments, the handle includes a finger loop that facilitates the user holding the device with a finger below the handle. Alternatively, the handle may comprise any other finger holding shape or other ergonomic shape for facilitating gripping of the device with one hand.

In another aspect of the present disclosure, a method for performing a surgical procedure in an ear canal of a patient may comprise: holding an otoscope with an attached suction device in one hand; advancing a distal end of an otoscope having an attached suction device into an ear canal of a patient; pressing a thumb pressing member of the suction device with a thumb of the hand to advance a suction shaft of the suction device relative to a visualization shaft of the otoscope; applying suction in the ear canal with a suction device; and observing the interior of the ear canal using the otoscope. In one embodiment, applying suction in the ear canal comprises: the fingers of the hand are applied to the open suction control openings on the handle.

In some embodiments, the method further comprises: releasing the thumb press to allow a spring on the suction shaft to expand to retract the suction shaft relative to a shaft of the otoscope. In some embodiments, depressing the thumb press member advances the suction shaft through a suction shaft insertion port on a handle of the ear endoscope and through a tool coupler attached to a shaft of the ear endoscope. A spring may be disposed on the suction shaft between the thumb pressing member and the handle. The method may also optionally include: a hand holding the otoscope is supported on the head of the patient during surgery.

These and other aspects and embodiments are described in more detail below with respect to the accompanying drawings.

Drawings

FIG. 1 is a perspective view of a surgeon's hand and the surgical field including the patient's ear, showing how prior art endoscopic and surgical tools are typically held;

FIG. 2 is a side view of an ear visualization system showing a suction device according to one embodiment;

FIG. 3 is an enlarged illustration of a distal portion of the ear endoscope shown in FIG. 2;

FIG. 4 is a perspective view of a coupler for use with an ear visualization system, according to one embodiment;

FIG. 5A is a side view of a combined visualization and aspiration device for ear surgery according to one embodiment;

FIG. 5B is a side view of the visualization/aspiration device of FIG. 5A, with the aspiration component advanced distally relative to the visualization component;

FIG. 5C is a side exploded view of the visualization/suction device of FIGS. 5A and 5B;

FIG. 5D is a front end view of the shaft of the combined visualization and suction device of FIGS. 5A-5C;

FIG. 6 is a perspective view of a surgeon's hand and an operating field including a patient's ear, illustrating how the combined visualization and suction device is held and used during ear surgery according to one embodiment; and

FIG. 7 is a side view of a combined visualization and aspiration device for ear surgery with a camera having a bend near a distal end of the camera, according to one embodiment;

FIG. 8 is a side view of a combined visualization and suction device for ear surgery according to another embodiment, wherein a sheath couples together a camera and a suction tube at an angle relative to each other;

fig. 9A to 9C are side, front and exploded views, respectively, of a combined visualization and suction device according to an alternative embodiment;

FIGS. 10A and 10B are side views of a portion of the combination of FIGS. 9A-9C illustrating a method for advancing and retracting a suction shaft relative to a visualization shaft according to one embodiment;

FIG. 11 is a perspective view of a portion of the head of a patient including the ears and the hand of a practitioner holding the combination of FIGS. 9A-10B;

FIG. 12 is a perspective view of a visualization component and a viewing system of the combination of FIGS. 9A-11, according to one embodiment;

FIGS. 13A-13C are right/rear perspective, left/rear perspective, and left side views, respectively, of an ear endoscopic device according to one embodiment;

FIG. 14A is a side view of the otoscope device of FIGS. 13A-13C with an alternative suction device for the otoscope according to one embodiment removed;

FIG. 14B is a side view of the otoscope and suction device of FIG. 14A, with the suction device attached to the otoscope;

FIG. 14C is a perspective view of the otoscope with suction device of FIGS. 14A and 14B shown in the left hand of a physician user;

FIG. 15 is a distal end view of a shaft of an otoscope according to an alternative embodiment.

FIGS. 16A and 16B are side views of an ear endoscope having a curved tip suction shaft, showing the suction shaft advanced distally (FIG. 16A) and retracted proximally (FIG. 16B), according to one embodiment;

FIG. 17 is a side view of an otoscope having a curved distal suction shaft and a handle having a finger ring according to an alternative embodiment;

18A-18D are perspective views of four different embodiments of thumb press members of an ear endoscope having a curved distal suction shaft;

FIG. 19 is a side view of an ear endoscopic device having an adjustable angled handle according to one embodiment;

FIG. 20 is a side view of an ear endoscopic device with a malleable handle, according to one embodiment;

fig. 21A is a side view of an ear tube placement and visualization and suction device advanced partway into the ear canal according to one embodiment;

fig. 21B is a side view of the device of fig. 21A illustrating placement of an ear tube through the tympanic membrane, according to one embodiment;

FIG. 22 is a side view of a curved distal end of an ear tube placement and visualization and aspiration device according to one embodiment; and

fig. 23 and 24 are side views of a portion of an ear visualization/suction device showing a removable handle adjustment component (fig. 24);

FIGS. 25 and 26 show a portion of the device of FIGS. 23 and 24 without the optional handle adjustment feature (FIG. 25) and a portion with the optional handle adjustment feature (FIG. 26);

fig. 27A and 27B are schematic views of the ear visualization/suction device of the present application, showing the orientation when the device is inserted in the right ear (fig. 27A) and in the left ear (fig. 27B) while being held by the left hand, according to one embodiment; and

fig. 28A and 28B are schematic views of the ear visualization/suction device of the present application, showing the orientation when the device is inserted in the right ear (fig. 28A) and in the left ear (fig. 28B) while being held by the left hand, according to an alternative embodiment.

Detailed Description

In general, embodiments described herein relate to an apparatus, system, and method for visualizing ear surgery. Ear visualization devices typically include an ear endoscope (or "camera") having an attachment mechanism for attaching an additional tool to the endoscope. Typically, the additional tool is a suction device, so the device provides visualization and suction through one device held by one hand. However, in alternative embodiments, any of a number of different tools may be attached to the endoscope in addition to or in place of the suction device. In some embodiments, an attachment mechanism for attaching the additional tool is built into the endoscope. Alternatively, the attachment mechanism may be a separate coupler or sheath that attaches to the shaft of the otoscope and allows any of a number of different types of surgical tools to be attached to the endoscope in a side-by-side arrangement. In other embodiments, visualization and aspiration may be provided integrally into the device. An ear visualization system may include an ear endoscope, as well as a separate attachment mechanism, a light source for the endoscope, a video monitor for displaying images captured by the endoscope, and/or any other suitable component. In some embodiments, the system may also include a suction device or other surgical tool. In other embodiments, the otoscopic apparatus or system can be provided by itself and can be used with one or more optional, independent tools.

As just mentioned above, in some embodiments, the attachment mechanism is a separate piece that can be removed from the endoscope shaft. In such embodiments, the endoscope and coupler may be referred to as a "system" by virtue of being a combination of two different devices. In alternative embodiments, the coupler may be integral with the endoscope shaft, or the coupler may be permanently attached to the endoscope shaft, in which case the endoscope with the coupler may be referred to as a "device". In any case, the use of the terms "system" and "device" herein should not be construed as limiting the scope of the present invention.

In some embodiments, the device may include an endoscope and a suction tube that also operates as an ear tube placement device. The distal tip of the suction/ear tube placement member may have a sharpened distal tip to pierce the tympanic membrane, and the device may further include a stopper for preventing the ear tube from sliding proximally upward above the suction/ear tube placement member. This device embodiment is described in further detail below.

The shaft of the otoscope, and any surgical tools used therewith, may have a very small diameter so that the distal end of the combined device may be easily inserted into the ear canal to aid in visualization and performance of the ear surgery. In some embodiments, the coupler surrounds a portion of the endoscope shaft and a portion of the surgical tool in the following manner: the shaft may rotate about the longitudinal axis of the tool and may also roll (or "turn") about the longitudinal axis of the shaft itself.

In one embodiment described in detail below, the surgical tool is an aspiration tube device. However, in alternative embodiments, the tool may be any suitable small diameter tool, such as, but not limited to: a cutting device, a piercing device, an ear tube placement device, an introducer, forceps, a speculum, a grasper, or an ear spoon. In the following description of the pumping embodiments, the following facts will not be repeated in the description of each embodiment: any other suitable size surgical tool may be substituted for the suction device. Similarly, the devices and methods described below for use in ear surgery may be used or adapted for use in any other suitable surgery. Also, this will not be repeated in the description of each embodiment.

Although the following description focuses on the use of an apparatus, system and method for visualizing and facilitating ear surgery, the same embodiments may be used or adapted for use in any other suitable procedure and part of the human or animal body. Thus, the present invention is not limited to use in the ear.

Referring now to FIG. 1, a prior art method of performing ear surgery using a standard endoscope 10 is shown. The figure shows an operating area in which the patient's ear E is exposed for surgery. The surgeon holds the endoscope 10 in his left hand L and the surgical tool 12 in his right hand. Due to the length of the endoscope 10, the surgeon must keep his left hand L suspended in mid-air above the patient in order to hold the handle of the endoscope 10. As mentioned earlier, this can be very awkward and potentially dangerous for the structure of the tympanic membrane and/or middle ear, especially in longer surgeries where the surgeon's left arm and left hand L may feel fatigued. Accordingly, since both of the surgeon's hands are occupied, the surgeon has no free hands to hold a suction device or other surgical tool. In order to perform suction in such a situation, the nurse or other assistant would have to hold the suction device in the patient's ear.

Referring to fig. 2, according to one embodiment, an ear procedure visualization system 100 can include an ear endoscope 102 and a coupler 112. Also shown in fig. 2 is a suction device 128, which suction device 128 is not necessarily part of the system 100, but the suction device 128 is shown in the figure for illustrative purposes. In alternative embodiments, the suction device 128 may be replaced by any other suitable surgical tool, such as those previously listed.

The otoscope 102 includes a handle 104, a shaft 106, and a processor 122, which processor 122 may also serve as a light source. Shaft 106 includes a proximal portion 107, a bend 108, and a distal portion 110, with distal portion 110 terminating in a distal tip 111. The endoscope 102 further includes: a light source 120 in the handle 104, and an optical fiber 118, the optical fiber 118 transmitting light from the light source 120 through the shaft 106 to the distal tip 111. An on-chip camera (described more fully below) may be positioned at the distal tip 111 to acquire images of the ear. The system 100 may also include a video monitor 126, but alternatively, the video monitor 126 may be a separate component that is not part of the system 100. In another embodiment, the processor 122 and the video monitor 126 may be combined in one unit.

The shaft 106 of the endoscope 102 may have an overall length of about 30 millimeters to about 80 millimeters and an outer diameter of less than about 2.5 millimeters. In some embodiments, the outer diameter of the shaft 106 may be continuous along the length of the shaft. Alternatively, the outer diameter of the distal portion 110 may be smaller than the outer diameter of the proximal portion 107. The bend 108 may form an angle between about 90 degrees and about 155 degrees between the proximal portion 107 and the distal portion 110. The handle 104 can be very small and lightweight compared to typical endoscope handles. Indeed, the handle 104 may be shaped with a comfortable pen-like grip so that the surgeon may hold and manipulate the otoscope 102 like a pen. The ear endoscope 102 can also include a cable 124, the cable 124 attaching the handle 104 to the processor 122.

The coupler 112 includes an endoscope attachment portion 114 and a tool attachment portion 116. In some embodiments, each of the two

portions

114, 116 is shaped as a tube or a semi-circular tube. In some embodiments, the endoscope attachment portion 114 and the tool attachment portion 116 may have the same diameter. Alternatively, the endoscope attachment portion 114 and the tool attachment portion 116 may have different diameters. For example, in some embodiments, the endoscope attachment portion 114 has a diameter that is larger than a diameter of the tool attachment portion 116. According to various alternative embodiments, the coupler 112 may be permanently attached to the shaft 106, or may be removable. As shown, the coupler 112 may be attached to the distal portion 110 of the shaft 106. Alternatively, the coupler 112 may be attached to the proximal portion 107, for example, if the shaft 106 is straight, or the coupler 112 follows the bend 108 in the shaft 106.

The weight, size, and feel of otoscope 102 may be similar to the weight, size, and feel of other ear surgical tools. This makes the surgeon more comfortable to hold and prevents imbalance between the otoscope 102 and other tools. The surgeon may hold the handle 104 with a pen-shaped grip and may rest her hand and/or the handle 104 on the patient's head during the surgical procedure. To achieve the desired weight, size, and feel, any suitable material may be used for the various portions of the ear visualization system 100. For example, in one embodiment, the handle 104 may be made of any suitable lightweight plastic and the shaft 106 may be made of any suitable metal, such as stainless steel. Alternatively, the handle 104 may be made of a lightweight metal. For example, the coupler 112 may be made of plastic or metal. Any suitable medically safe material may be used.

As mentioned above, a suction device 128 is shown in FIG. 2, the suction device 128 being attached to the shaft 106 of the endoscope 102 via the coupler 112 in a side-by-side arrangement. In alternative embodiments, any other means may be substituted for the suction device 128. The suction device 128 is also shown having a suction source 130, and the suction source 130 may be a separate component, a wall suction source, or any suitable suction source. The suction tube portion of the suction device 128 is flexible, at least along a portion of its length, and has a distal portion with an outer diameter that fits within the tool attachment portion 116 of the coupler. Various embodiments and features of the suction device 128 are described in further detail below.

Referring now to fig. 3, the distal portion 110 of the endoscope shaft 106 is shown in greater detail. At the distal end 111 of the shaft 106, an imaging sensor 140 and two light sources 142 are positioned. The imaging sensor 140 may be any type of suitable sensor, such as a Complementary Metal Oxide Semiconductor (CMOS) camera, or any other "camera on a chip" type device. For example, the two light sources 142 (or alternatively, any other number of light sources) may be Light Emitting Diode (LED) lights. These may be in addition to or in place of the light source 120 shown in the handle 104 in fig. 2. In other words, the one or more light sources for the endoscopic device 102 may be positioned in the handle 104, at the distal end 111 of the shaft 106, or both, according to various embodiments.

FIG. 4 is an enlarged view of an alternative embodiment of a coupler 212 for use with the ear endoscope 102. The coupler 212 includes an endoscope attachment portion 214, a tool attachment portion 216, a longitudinal top opening 250 in the tool attachment portion 216, and a longitudinal middle opening 252 between the endoscope attachment portion 214 and the tool attachment portion 216. In this embodiment, the endoscope attachment portion 214 has a diameter that is larger than the diameter of the tool attachment portion 216. The tool (not shown) may be inserted into the tool attachment portion 216 by pushing the tool downward through the top opening 250, or sliding the tool into the proximal end of the tool attachment portion 216 and advancing the tool distally. In the event that a tool is pushed through the top opening 250, the coupler 212 may flex slightly outward to accommodate the tool by expanding at both

openings

250, 252. In alternative embodiments, endoscope attachment portion 214 and/or tool attachment portion 216 may be formed as a complete tube having a circular cross-section rather than a semi-circular cross-section. As mentioned above, the coupler may be made of any suitable material.

Referring to fig. 5A-5D, one embodiment of an ear procedure visualization device 20 is shown. In this embodiment, visualization device 20 (which may also be referred to as a "combined visualization and aspiration device") includes aspiration tube 22, camera 30, and coupler 38 (or "sheath"), which coupler 38 is disposed about aspiration tube 22 and camera 30. Suction duct 22 has: a distal end 24, a proximal end 26 for connection to a suction line connected to a suction source, and a bend 28 along the length of the suction tube. Camera 30 includes a distal portion 32, a proximal portion 36, and a distal end 34.

Aspiration tube 22 may be any standard or custom-made aspiration tube device. In various embodiments, aspiration tube 22 may be rigid and may be made of any suitable material, such as stainless steel, or other biocompatible metals or plastics. Aspiration tube 22 has an overall diameter and length that allows it to be easily advanced into the ear during surgery and allows the surgeon to hold visualization device 20 resting on the patient's head with one hand. In some embodiments, for example, aspiration tube 22 has an outer diameter of about 0.6 millimeters to about 1.1 millimeters at least along the portion between bend 28 and distal end 24. The bend 28 in aspiration tube 22 is optional and alternative embodiments may be straight. However, the bend 28 may be advantageous because the bend 28 allows the visualization device 20 to be held at an angle to the ear such that the hand holding the visualization device 20 is not in the direct line of sight of the surgeon. This is particularly advantageous in the case where the surgeon wants to use microscope and visualization device 20 in the same surgical procedure, however it is also advantageous to have aspiration tube 22 and camera 30 not interfere with any surgical tools held by the surgeon's other hand. In various embodiments, for example, bend 28 may be located about 40 mm to about 100mm from distal end 24 of aspiration tube 22. In one embodiment, the bend may be about 60 millimeters from the distal end 24. In an alternative embodiment of device 20, in which camera 30 is combined with a different type of surgical tool other than aspiration tube 22, the surgical tool may also include the same or similar bends.

Camera 30 may be any suitable small diameter camera for viewing the ear during ear surgery. In some embodiments, for example, camera 30 may be a fiber optic camera, or a Complementary Metal Oxide Semiconductor (CMOS) camera. Since cameras of small diameter are well known, they will not be described in detail here. In some embodiments, at least the distal portion 32 of the camera 30 may be relatively rigid such that the surgeon may easily roll the distal portion 32 about its longitudinal axis, and/or rotate the distal portion 32 relative to the aspiration tube 22. In some embodiments, the camera 30 may include a bend that may coincide with the bend 28 in the suction tube. The camera 30 may include a CMOS sensor with a lens array. In some examples, the sensors may be arranged in tiles between 0.6mm by 0.6mm and 1.0mm by 1.0mm, with a total length of up to 3 mm. Alternative embodiments may include fiber optic bundles for image capture other than CMOS. The light source for illumination may be an LED at the distal end 34, or an optical fiber filled with light from a remote LED.

The cross-sectional shape of the camera 30 may vary in different embodiments (circular, oval, square, rectangular, etc.), but in the illustrated embodiment, the camera 30 has a circular cross-sectional shape. This is advantageous for rolling and rotating camera 30 within coupling 38 and relative to aspiration tube 22. The body of camera 30 is made of a relatively rigid or at least semi-rigid material, such as stainless steel or plastic (e.g., thermoplastic). The length of distal portion 32 may be, for example, about 5mm to about 100 mm. In some embodiments, distal portion 32 may be as long as the length of evacuation tube 22 from distal end 24 of the evacuation tube to curved portion 28, and in one embodiment is about 60 mm. In various embodiments, the camera 30 and light source may be integrally provided into a metal tube, overmolded with plastic, encapsulated in a polymer, or the like.

According to various embodiments, the coupler 38 may be any suitable material and have any suitable length, thickness, and dimensions. In one embodiment, coupling 38 is formed as a tube of heat shrinkable polymer wrap around the distal portion of aspiration tube 22 and the distal portion of camera 30. In some embodiments, the heat shrinkable polymer may be polyethylene terephthalate (PET), or alternatively, may be any other suitable polymer, such as, but not limited to: polyolefin, polyimide or nylon. As shown in fig. 5A and 5B, in one embodiment, the coupling 38 is disposed about the suction tube and the camera 30 such that the suction tube 22 can be advanced (fig. 5B) and retracted (fig. 5A) relative to the coupling 38 and the camera 30. For example, in some embodiments, the aspiration tube 22 may be advanced from a position where the distal end 24 of the aspiration tube is at or near the distal end 34 of the camera 30 (fig. 5A) to a position where the distal end 24 of the aspiration tube is in front of the camera 30 (fig. 5B). In this embodiment, the camera 30 is also capable of sliding forward and backward. In alternative embodiments, camera 30, aspiration tube 22, or both camera 30 and aspiration tube 22, may be secured to an inner surface of coupling 38, such as by an adhesive, to reduce the amount that one or both components may be moved relative to coupling 38.

Fig. 5C is an exploded view of ear procedure visualization device 20, showing aspiration tube 22, camera 30, and coupler 38 separated from one another. For assembly, in some embodiments, coupler 38 may wrap around aspiration tube 22 and camera 30, or slide over aspiration tube 22 and camera 30.

Fig. 5D shows possible directions of movement of camera 30, aspiration tube 22, and coupling 38 relative to one another. In some embodiments, as described above, coupler 38 may be positioned around camera 30 and aspiration tube 22 but not fixedly attached to camera 30 and aspiration tube 22. In addition to allowing aspiration tube 22 and/or camera 30 to advance longitudinally through coupling 38, this configuration also allows aspiration tube 22 and camera 30 to roll about their own axes within coupling 38 (two small hollow arrows around the perimeter of coupling 38). In addition, camera 30 may be rotatable about the longitudinal axis of aspiration tube 22 (larger open arrow). Aspiration tube 22 may also be rotatable about the longitudinal axis of camera 30. This freedom of movement (rotation and roll) allows the surgeon to easily and quickly adjust the orientation of camera 30 and/or aspiration tube 22 without having to change the orientation of the two components. Again, however, in alternative embodiments, coupler 38 may be adhered or otherwise fixedly attached to one or both of camera 30 and aspiration tube 22.

Fig. 6 shows the surgical field including the patient's ear E, the surgeon's left hand L and right hand R, and the surgery is performed on the ear E. The surgeon's left hand L is holding an ear procedure visualization device 20, which ear procedure visualization device 20 includes suction tube 22 and camera 30, as described above. Aspiration tube 22 is attached proximally to aspiration tube 40, which aspiration tube 40 is in turn attached to an aspiration source (not shown). The surgeon's right hand R holds the surgical tool 12. As shown by the large arrows in the figure, the surgeon's hands approach the ear E from two different angles, leaving a direct line of sight (indicated by the hollow arrow in the middle/upper right) from the surgeon's eye to the patient's ear E. This arrangement will allow the surgeon to visualize the surgical field using the microscope and camera 30, if desired. As also shown in fig. 6, ear visualization device 20 is sized and shaped so that a surgeon may rest her hand on the patient's head during a surgical procedure. In performing this (surgical) procedure, the surgeon may advance device 20 into ear E, suction tube 22 to suction ear E, camera 30 to visualize ear E, and perform the (surgical) procedure. Alternatively or additionally, aspiration tube 22 may be used to hold on and move one or more small anatomical structures of the ear, such as, but not limited to, the bone of the middle ear. Suction may also be used to hold different devices, such as ear tubes or auditory ossicle prostheses. The device 20 is typically small enough so that the camera 30 can be used to visualize the middle ear through a natural hole or incision in the tympanic membrane. The actions may be performed in any order and in any combination. In some embodiments, the surgeon may separate camera 30 from aspiration tube 22 during ear surgery, so camera 30 and aspiration tube 22 may be used separately.

In some embodiments, the ear procedure visualization device 20 can be used with another, different ear procedure visualization device (not shown). For example, the combined camera/aspiration tube device 20 may be held in the non-dominant/dominant hand of the surgeon and the combined camera/surgical tool device may be held in the dominant/dominant hand of the surgeon. The two devices 20 may be used simultaneously to acquire two images of the ear. Views from both cameras may be displayed on a single split-screen video screen, for example, with the right half labeled "R" and the left half labeled "L". In all embodiments, the video screen may be separate and located above the patient's head and within the field of view of the microscope, so that the surgeon can view the surgical field through the microscope, can view the endoscopic view through the microscope, or simply switch from viewing through the microscope to viewing the video screen. In another embodiment, the endoscopic images may be fed digitally into the microscope so that the surgeon can view both of them through the microscope, or toggle between them, for example, by pressing a button.

Referring now to fig. 7, an alternative embodiment of an ear surgery visualization/aspiration device 50 is shown. As described above, in some embodiments, aspiration tube 22 may be advanced relative to camera 30 such that distal end 24 of aspiration tube 22 is positioned forward of distal end 34 of camera 30, as shown in fig. 5B. In embodiments where the distal portion of the evacuation tube 22 and the distal portion of the camera 30 are both straight and connected parallel to each other, the evacuation tube 22 may interfere with the field of view of the camera 30 in this configuration. The embodiment of the apparatus 50 shown in fig. 7 is configured to address this problem. In this embodiment, the distal portion 32 of the camera 30 includes a bend 52. This bend 52 orients the field of view 54 of camera 30 at an angle relative to the longitudinal axis of aspiration tube 22 and the longitudinal axis of camera 30 so that aspiration tube 22 does not interfere with or restrict field of view 54. In various embodiments, the bend 52 may be located anywhere along the length of the camera 30, although in many embodiments, the bend 52 will be located near the distal end 34 such that the bend 52 is distal with respect to the distal end of the coupler 38.

Referring now to fig. 8, another alternative embodiment of an ear surgery visualization/aspiration device 60 is shown. This embodiment is an alternative way of solving the problem of aspiration tube 22 intercepting a portion of camera's field of view 54. In this embodiment, the sheath 68 has a wider distal end 64 and a narrower proximal end 66. Thus, sheath 68 couples camera 30 and aspiration tube 22 together such that camera 30 and aspiration tube 22 are angularly oriented relative to one another. In other words, camera 30 and aspiration tube 22 are not parallel to each other. As with the previous embodiment, this helps prevent the field of view 54 of camera 30 from being restricted by aspiration tube 22.

Referring now to fig. 9A-9C, one embodiment of an ear visualization system 300 is shown. The ear visualization system 300 includes an ear endoscope 302 and an optional suction device 310. The ear endoscope 302 includes a handle 304, a shaft 306 extending from one end of the handle 304, two tool couplers 307a, 307B (see fig. 9B) on either side of the shaft 306, and a cable 308 extending from the opposite end of the handle 304. The imaging components extend through the handle 304, shaft 306, and cable 308, which may be any of those described above and are not shown in these figures. The handle 304 comprises two suction shaft holes 305a, 305b (not visible in these figures, since the suction shaft holes are on the top surface of the handle 304) through which the shaft 316 of the suction member 310 is advanced. The shaft 316 of the suction component 310, after exiting the distal end of the respective bore 305a, 305b, advances through one of the two

tool couplings

307a, 307 b. The handle 304 may have any of a number of suitable sizes, shapes, and weights, but in this embodiment the handle 304 is configured as a pen-like grip that is easily held by the practitioner. In some embodiments, the handle 304 may be made of a lightweight plastic.

The suction component 310 includes a suction tube 312, a thumb press portion 314, a suction control aperture 320, a suction shaft 316 having a distal end 317, and a spring 318 disposed on the suction shaft 316 between the thumb press portion 314 and the handle 304. The suction shaft 316 extends through the suction shaft aperture 305a in the handle 304, through the tool coupling 307a, and alongside the visualization member shaft 306. As will be described further below, the user physician may press the thumb press portion 314 to advance the distal end 317 of the suction shaft 316 beyond the distal end of the visualization shaft 306 and further into the ear. When the user releases the thumb press 314, the spring 318 automatically retracts the suction shaft 316 along the visualization shaft 306 through the tool coupling 307a and the aperture 305 a. The physician may cover the suction control aperture 320 with the index finger (or other finger) to apply suction, and the physician may remove the finger from the aperture to remove or reduce suction at the distal end 317 of the suction shaft 316.

Fig. 9B is a front view of ear visualization system 300, showing that this embodiment includes two suction tool couplers 307a, 307B, one on each side of visualization member shaft 306. Thus, this embodiment also includes two suction shaft holes 305a, 305b, each feeding one of the two

suction tool couplers

307a, 307 b. Two

tool couplings

307a, 307b facilitate holding and manipulating the device 300 with either the right or left hand and placement of aspiration tubing/other tools under or over the camera sensor. In some embodiments, the visualization component shaft 306, the

tool couplers

307a, 307b, and the suction shaft 316 can be made of metal, such as stainless steel or other biocompatible metal. In some embodiments, the visualization member shaft 306 has an outer diameter of about 2.5 millimeters or less. Similarly, each of the

tool couplers

307a, 307b may have an outer diameter of about 2.5 millimeters or less. The outer diameter of the suction shaft 316 is sized to fit through the inner diameter of the

tool couplers

307a, 307 b. In some embodiments, the suction shaft 316 may have an outer diameter of about 1.1 millimeters or less.

Fig. 9C is a side view of ear visualization system 300 with ear endoscope 302 detached from suction device 310. In this embodiment, the ergonomic design of the handle 304 may be important to facilitate the operation of the system 300 by a physician. For example, the handle 304 includes finger gripping features 322, which finger gripping features 322 may allow the handle 304 to be easily gripped with a middle finger (or other finger). The index finger of the user may be used to control the suction control aperture 320 and the thumb of the user may be used to control the thumb press portion 314 of the suction assembly 310. In one other embodiment described below, the finger grip feature 322 may comprise a loop, a resilient loop, or any other suitable shape.

In various alternative embodiments, one or more modifications may be made to the ear endoscopic device 300. For example, in some embodiments, the

couplings

307a, 307b may extend the entire length of the endoscope main shaft 306 (or along a longer portion rather than the entire length). In some embodiments, there may be only one coupler and one aperture, rather than two

couplers

307a, 307b and two apertures 305a, 305 b.

Referring to fig. 15, in yet another alternative embodiment, an otoscope shaft 500 may include an outer shaft body 502, a tool guide 504 forming a tool cavity 506, two

light sources

508a, 508b, and an imaging sensor. In this embodiment, tool guide 504 and tool lumen 506 are located inside outer shaft body 502, unlike the previously described embodiments where the suction tube is placed on the outside of the endoscope main shaft through a coupler. In some embodiments, a tool guide 504 may be used to apply suction or advance a suction device through the shaft 500. Alternatively, the tool guide 504 may be used to advance any other suitable tool through the otoscope shaft 500, such as any of the tools listed in this application. This embodiment of fig. 15 may be applied to any of the endoscopic embodiments described above or below to produce alternative embodiments.

Fig. 10A and 10B illustrate a method of advancing and retracting the suction shaft 316 in the ear visualization system 300 according to one embodiment. In fig. 10A, the physician presses the thumb pressing portion 314 of the suction member 310 with her thumb T. This advances the suction shaft 316 through the handle 304 and tool coupling 307a, thereby advancing the suction shaft 316 along the side of the visualization shaft 306. Thus, the distal end 317 of the suction shaft 316 will be advanced further down into the ear of the patient. In this configuration, the spring 318 is compressed. In fig. 10B, the practitioner has released her thumb T from the thumb press portion 314, allowing the spring 318 to expand and retract the aspiration shaft 316 proximally through the tool coupling 307a and handle 304. Thus, the physician can easily adjust the position of the distal end 317 of the aspiration shaft 316 relative to the visualization shaft 306.

In various embodiments, the distal end 317 of the aspiration shaft 316 may be positioned at a plurality of different locations relative to the distal end of the visualization shaft 306. When the aspiration shaft 316 is fully advanced, the distal end 317 of the aspiration shaft may be at, near, or distal to the distal end of the visualization shaft 306. Similarly, when the aspiration shaft 316 is fully retracted, the distal end 317 of the aspiration shaft may be located at, near, or away from the distal end of the visualization shaft 306. For example, in one embodiment, the distal end 317 of the aspiration shaft 316 may be depressed and then advanced to a position beyond the distal end of the visualization shaft 306 in the distal direction, even with the distal end of the visualization shaft 306 in a fully retracted position. In another embodiment, in the fully retracted position, the distal end 317 of the aspiration shaft 316 may be disposed more laterally than the distal end of the visualization shaft 306, and then the distal end 317 of the aspiration shaft 316 may be advanced to a position even the distal end of the visualization shaft 306. Any combination of positions is possible according to different alternative embodiments.

Referring to fig. 11, the physician's hand H is shown holding the combined device 300 over the anatomical model. As shown, the handle 304 fits comfortably in the hand H with the middle finger at the bottom and the index finger at the top. The thumb is positioned on the thumb press portion 314 and the visualization member shaft 306 and the suction shaft 316 extend into the model. During ear surgery, a physician may rest his or her hands on the patient's head to provide support and stability and to prevent arm fatigue. The overall very light weight of the handle 304 and device 300 generally makes it easy to manipulate and hold.

Referring now to fig. 12, in some embodiments, an ear visualization system 300 can include an ear endoscope 302 and a viewing system 330. The viewing system may include a video monitor 336, a console 332, and a cable 334 connecting both the video monitor 336 and the console 332. The console 332 may include a connector 338, and a connector 337 on the visualization component 302 is inserted into the connector 338. According to various embodiments, the various portions of the viewing system 330 may be any suitable off-the-shelf components or custom components. In an alternative embodiment, instead of having a separate video monitor 336, the console 332 may include a built-in screen, and the endoscope 300 would be connected to the console 332. In various embodiments, the ear endoscope 302 can be provided with the viewing system 330, the suction device 310, or as a stand-alone device.

Referring now to fig. 13A-13C, another embodiment of an ear endoscope 400 is shown. In this embodiment, the ear endoscope 400 includes: a handle 402 with a finger ring 404; a shaft 406; two

tool coupling shafts

408a, 408 b; two side suction

tubing connection ports

410a, 410 b; two suction

tube insertion ports

412a, 412 b; a rear suction tube connection port 414; and a sensor interface cable 416. In this embodiment, the ear endoscope 400 may be provided as a separate unit and may be used with an additional suction device, or the ear endoscope 400 may be provided with a suction device. In either case, the suction supply device may be connected to a rear suction tube connection port 414, the rear suction tube connection port 414 being in fluid communication with a suction lumen extending through the handle 402 and exiting at both side suction

tube connection ports

410a, 410 b. One of the two side suction

tube connection ports

410a, 410b, in turn, may be connected to a short suction tube that is connected to a suction shaft that extends through one of the suction

tube insertion ports

412a, 412b and one of the

tool coupling shafts

408a, 408b, as will be described further below. The physician may hold either of the two suction

tube connection ports

410a, 410b open for suction control by placing a finger on the open suction

tube connection port

410a or 410b to apply suction, or releasing a finger from the open suction

tube connection port

410a or 410b to close suction.

The finger ring 404 on the handle 402 may be flexible in some embodiments, and rigid in other embodiments. In alternative embodiments, the finger ring 404 may have any other suitable shape or size to facilitate grasping of the endoscope 400. The ring 404 allows the physician user to hold and operate the ear endoscope 400 with one hand. In practice, the finger ring 404 may allow the physician to hold the handle 402 with one finger (e.g., middle finger) and operate other functions of the device 400 with other fingers. For example, the user may pass the middle finger through the finger ring 404, advance the suction tube using the thumb of the same hand, and control suction using the index finger of the same hand by covering and uncovering the

open port

410a or 410 b. Alternatively, the fingers may be placed on the handle 402 and used in different configurations on the handle 402. As is evident from fig. 13A-13C, the shaft 406 is straight in this embodiment, but the shaft 406 is angled relative to the handle 402 so that the entire endoscopic device 400 is angled to allow the physician to place the shaft 406 in the ear canal without obstructing the direct viewing path into the ear canal.

Referring now to fig. 14A-14C, the ear endoscope 400 of fig. 13A-13C is now shown with an optional suction device 420. Fig. 14A shows suction device 420 detached from ear endoscope 400. The suction device 420 includes a suction shaft 422 connected to a thumb press member 424, the thumb press member 424 being connected to a side suction tube 426. A spring is provided on a proximal portion of the suction shaft 422 to provide automatic retraction of the suction shaft 422 relative to the main shaft 406 of the endoscope 400 when the user releases pressure on the thumb press member 424. Suction device 420 may also include a rear suction tube 428. The suction shaft 422 extends through either of the two suction

tube insertion ports

412a, 412b, and thus through the corresponding

tool coupling shaft

408a, 408 b. A side suction tube 426 may be connected to either of the two side suction

tube connection ports

410a, 410b, leaving the opposing

side port

410a, 410b open for finger control of suction. In addition, a rear suction tube 428 is attached to the rear suction tube connection port 414 in order to supply suction force from a suction supply device (such as wall suction, can suction, etc., not shown in fig. 14A) to the suction device 420. As explained above, a suction lumen (not visible in the figures) in the handle 402 of the endoscope 400 connects the rear suction tube connection port 414 with the two side suction

tube connection ports

410a, 410 b.

Fig. 14B shows all the components of suction device 420 attached to an otoscope. As shown in this figure, the spring 418 is located on the suction shaft 422 and between the bottom surface of the thumb press member 424 and the top surface of the handle 402. When the user presses down on the thumb press member 424, the suction shaft 422 advances distally along the main shaft 406 and the spring 418 compresses. When the user then releases pressure on the thumb press 424, the suction shaft 422 automatically retracts proximally relative to the handle 402 and the main shaft 406.

Fig. 14C shows the left hand H of the physician holding the combined otoscope 400 and suction device. As shown here, the physician's thumb is positioned on the thumb pressing member 424 and is used to advance the aspiration shaft 422. The physician's middle or ring finger may be placed through the finger loop 404 of the handle 402 and the physician's index finger may be placed on or removed from the open side suction tube connection port 410b to control the suction applied through the suction shaft 422. If the practitioner prefers to hold the otoscope 400 with his right hand, the side suction tube 426 and suction shaft 422 can simply be switched to the opposite side of the otoscope 400.

Fig. 15 is a cross-sectional view of a distal/shaft portion of an ear visualization device 500 according to an embodiment. The portion of the apparatus 500 shown in fig. 15 may be used with any of the embodiments described above or below. The illustrated portion of the device 500 includes an outer shaft 502 with an aspiration shaft 504 forming an aspiration lumen 506 within the outer shaft 502. The camera 510 and the two sets of

optical fibers

508a, 508b are also located inside the outer shaft 502, the two sets of

optical fibers

508a, 508b being shown as rectangular, but may be bundled into a circle, oval, or any other suitable shape. In some embodiments, the interior of the outer shaft 502 may be solid or filled with material, and the camera 510 and the

optical fibers

508a, 508b may reside in a cavity formed within the material in the outer shaft 502. The camera 510 may be located at or near the distal end of the outer shaft 502 and may be any type of suitable camera, such as, but not limited to: a Complementary Metal Oxide Semiconductor (CMOS) camera, or a Charge Coupled Device (CCD) camera. The light source may also be any type of suitable light source, including but not limited to:

optical fibers

508a, 508b, one or more Light Emitting Diodes (LEDs), and the like. Again, this is but one exemplary embodiment of a shaft portion of the device 500.

Fig. 16A and 16B illustrate another embodiment of an ear visualization/suction device 600. As with the previous embodiment, the apparatus 600 includes: the handle 602, the main shaft 606 (or "endoscope shaft" which includes a camera at the distal end), the suction guide shaft 607 on the side of the main shaft 606, a thumb press portion 624 attached to the suction shaft 622 and suction tube 626, and a spring 618 disposed on a portion of the suction shaft 622, such that when the user releases the thumb from the thumb press portion 624, the spring 618 causes the suction shaft 622 to automatically retract (as shown in fig. 16B). In this embodiment, the suction shaft 622 of the ear visualization/suction device 600 also includes a curved distal tip 623 and the thumb press portion 624 includes a surface feature 628. The physician user can apply pressure to the thumb press 624 (as shown in fig. 16A) and use surface features 628 (which are protrusions in this embodiment) to rotate the thumb press 624 and thereby rotate the aspiration shaft 622 and curved distal end 623. In this manner, the suction distal end 623 can be directed in a plurality of different directions to suction different areas within the ear. The curved distal tip 623 can have different shapes and angles, and the surface features 628 can also have many different shapes and configurations, some of which are described in further detail below. For example, in an alternative embodiment, the tip of the curved distal end 623 may be beveled rather than a blunt/flat end as shown in fig. 16A and 16B, and the curved distal end 623 may help facilitate suction on a surface as the distal end 623 is rotated.

Fig. 17 shows another embodiment of an ear visualization/suction device 700. This embodiment also includes a handle 702, in which case handle 702 is attached at its proximal end to an endoscope cable 730 and suction tube 732, both endoscope cable 730 and suction tube 732 passing through the body of handle 702 to the front/distal end of handle 702. Suction tube 732 passes through the body of handle 702 and terminates in two suction ports 708 (only the left port is visible in fig. 17), one on each side of handle 702. One suction port 708 is attached to a short suction tube 712, which short suction tube 712 in turn is attached to a suction port 710 on a freely rotating suction member 715, which freely rotating suction member 715 is arranged on a suction shaft 722 and freely rotates around the suction shaft 722. The suction ports 710 on the free-wheeling suction member 715 are in fluid communication with the lumen of the suction shaft 722 such that suction passes through the ports 710 and into the lumen of the suction shaft 722. In use, suction travels from suction tube 732, through handle 702, suction port 708, short suction tube 712, suction port 710, and suction shaft 722, down to the distal end of suction shaft 722. The physician user will cover the opposite side open suction port (which corresponds to 708, but is on the side of the handle 702 not visible in fig. 17) with his finger to apply suction to the suction shaft 722 and release his finger from the open suction port to allow outflow of suction from the open suction port and thereby prevent suction flow through the suction shaft 722.

As with the previously described embodiments, the ear visualization/suctioning device 700 includes a main shaft 706, the main shaft 706 including a camera at a distal end of the main shaft for visualizing the ear. The ear visualization/aspiration device 700 further comprises an aspiration guide shaft 707 and an aspiration shaft 722 with a curved distal end 723. The device 700 may further include a spring 718, the spring 718 disposed on a proximal portion of the suction shaft 722 between a top of the handle 702 and a bottom of the freely rotating suction member 715. The freely rotating suction member 715 is disposed on a proximal portion of the suction shaft 722, just below a thumb pressing member 724, which thumb pressing member 724 in turn comprises a surface feature 728. A free-rotating suction member 715 receives two O-rings 714, one of which is positioned above the hole in suction tube 722, port 710 opens into the hole in suction tube 722, and one of which is positioned below the hole. The free-wheeling suction member 715 and O-ring 714 form a liquid-tight chamber that conveys suction from the short suction tube 712 through the suction port 710 on the free-wheeling suction member 715 and finally into the suction shaft 722. At the same time, the suction shaft 722 may rotate while the freely rotating suction member 715 stays in one position (does not rotate), thereby preventing the short suction tube 712 from twisting around the suction shaft 722. Again, in this embodiment, when the user rotates the thumb pressing member 724 using the surface features 728, the free-wheeling suction member 715 does not rotate with the thumb pressing member 724 or the suction shaft 722, but rather remains in the same position as the suction shaft 722 rotates by free-wheeling on that suction shaft 722. Thus, the suction port 710 does not rotate with the suction shaft 722, but stays in one position. This is important because if the freely rotating suction member 715 rotates along with the suction port 710, along with the thumb press 724 and the suction shaft 722, the short suction tube 712 will twist about the suction shaft 722 and make it difficult for the user to rotate the suction shaft 722. This will also prevent free continuous 360 degree rotation of the suction shaft 722 and may also potentially result in pulling one of the

suction ports

708, 710 out, turning the suction shaft 722 back to its original orientation, or even impeding ingress and egress of the suction shaft 722 into the ear. Advantageously, the freely rotating suction member 715 allows the user to continuously rotate the thumb press member 724 and suction shaft 722 360 degrees or more to a desired degree without twisting the short suction tube 712.

An additional feature of this embodiment of the ear visualization/suction device 700 is an adjustable finger ring 704 on a handle 702. In this embodiment, the user may place her finger (e.g., her middle or index finger) through the loop portion of the finger ring 704 and pull the free end of the finger ring 704 to tighten the loop portion. The loop portion may also be pulled to make the loop portion larger. This is just one example of a finger hold member that may be included on handle 702 to facilitate holding handle 702 with one finger. In one embodiment, the user may hold the device 700 with the middle finger through the ring 704 and operate the device 700 with the other fingers of the same hand (e.g., index finger and thumb).

Fig. 18A-18D are perspective views of a portion of an ear visualization/suction device according to four different embodiments, each embodiment including a thumb press member of a different configuration for rotating a suction shaft having a curved distal tip. Referring to fig. 18A, one embodiment of an ear visualization/suction device 800 includes a generally circular thumb press member 802, the thumb press member 802 having an elliptical eccentric raised surface feature 804. The thumb press member 802 also includes a slightly concave upper surface for receiving a thumb. Having an off-center surface feature 804 allows the user to rest a finger (typically a thumb) against the surface feature 804 and ergonomically ease rotation of the suction shaft. Also shown in this and the following embodiments are a handle 801, a handle suction port 808, a suction shaft 810, and a suction shaft suction port 806.

In the embodiment of fig. 18B, ear visualization/suction device 810 includes a rounded-like, slightly concave thumb press member 812, the thumb press member 812 having a more rounded-shaped (or oval-shaped) surface feature 814. In the embodiment of fig. 18C, ear visualization/suction device 820 comprises an asymmetric bean-shaped thumb press member 822, the thumb press member 822 having a rounded-shaped (or oval-shaped) raised surface feature 824 on a lateral portion of the thumb press member 822. In the embodiment of fig. 18D, the ear visualization/suction device 830 comprises another asymmetric thumb press 832 with a convex upwardly curved edge on one side of the thumb press 832. As shown in fig. 18A-18D, in any given embodiment, the thumb pressing member and surface features may have any suitable shape, size, and configuration.

Referring now to fig. 19, another embodiment of an ear visualization/aspiration device 900 is shown. This embodiment includes many of the features of the previous embodiments and will not be described in detail herein. In addition, this embodiment of the device 900 includes an adjustable handle 902, which adjustable handle 902 may make holding the handle 902 more comfortable for a given user. The handle 902 has: a distal portion 904, a proximal portion 906, and an adjustment member 908 between the distal portion 904 and the proximal portion 906. The adjustment member 908 acts like an axis to allow the proximal portion 906 to rotate downward (and back upward as needed) so that the proximal portion 906 can be angled relative to the distal portion 904. Thus, regardless of whether the device 900 is used in the left ear or the right ear, the user can direct the tip of the device 900 in the direction of the ear canal (typically up-back) without changing the orientation of the user's entire hand. In various embodiments, the adjustment member 908 may have a particular adjustment angle at which the proximal portion 906 snaps in, and/or may have a locking feature that allows a user to lock the proximal portion 906 at a desired angle. In alternative embodiments, the adjustment member 908 may be positioned further distally or more proximally along the body of the handle.

Referring now to fig. 20, in another embodiment, ear visualization/suction device 1000 can include a handle 1002, the handle 1002 being malleable or including malleable segment 1004. As with similar embodiments, the malleable section 1004 allows the user to create an angle in the handle 1002, which may enhance ergonomics and comfort.

Referring now to fig. 21A and 21B, one embodiment of an ear tube placement device 1100 is shown. In this embodiment, the ear tube placement device 1100 also functions as an ear visualization/aspiration device. Ear tubes are typically placed in the tympanic membrane TM (or "eardrum") between the outer ear (or "ear canal", labeled "EC" in the figures) and the middle ear, primarily for children, but also for adults with frequent ear infections or other problems involving the middle ear. While one handle/suction tube configuration is shown in fig. 21A and 21B, alternative embodiments may include any of the handle/suction configurations described in the present disclosure. As with the previously described embodiments, the device 1100 includes a handle 1102, a thumb press 1104, an aspiration tube 1106, a main shaft 1114, an aspiration guide tube 1112, an aspiration shaft 1110, and a spring 1108 positioned on a proximal portion of the aspiration shaft 1110. This embodiment also includes a stop member 1120 located near the distal end of the aspiration shaft 1110, and a sharpened distal tip 1116 on the aspiration shaft 1110. Ear tube 1118 may be part of device 1100, or more likely, ear tube 1118 may be any currently available or to be developed ear tube that is placed on the distal end 1116 of the suction shaft.

Fig. 21A shows the ear tube placement device 1100 in a pre-deployment position with the ear tube 1118 mounted on the suction shaft 1110 and the distal end of the device 1100 advanced into the ear canal EC. The thumb pressing member 1104 has not been pressed. Fig. 21B shows device 1100 in position to deploy ear tube 1118 in the tympanic membrane TM. In use, the suction shaft 1110 will typically be advanced toward the TM until the sharpened distal tip 1116 of the suction shaft 1110 presses against the tympanic membrane TM to pierce the tympanic membrane. Next, the suction shaft 1110 is further advanced to push the ear tube 1118 through a new hole in the tympanic membrane TM, as shown in fig. 21B. When the ear tube 1118 is pushed through the hole, the stop member 1120 prevents the ear tube 1118 from being pushed back by the TM and sliding back over the suction shaft 1110 as the suction shaft 1110 advances through the TM. The stop member 1120 may be any suitable feature or surface feature on the aspiration shaft 1110 (or of the aspiration shaft 1110), such as, but not limited to, a washer-like member, a raised ring on the aspiration shaft 1110, another tube disposed on the aspiration shaft 1110, and so forth. Generally, any feature or feature that would prevent ear tube 1118 from sliding proximally during deployment would be suitable. After the ear tube 1118 is placed in the tympanic membrane TM, the suction shaft 1110 and/or the entire device 1100 can be retracted/pulled back to slide the suction shaft 1110 out of the ear tube and slide the device 1100 out of the ear canal.

Fig. 22 shows the distal end of an alternative embodiment of an ear tube placement device 1200. In this embodiment, the spindle 1202 includes a camera (not visible) as in the previously described embodiments. The aspiration shaft 1204 is curved and terminates in a sharp distal tip 1208. Stop member 1210 is disposed on the suction tube and ear tube 1206 is shown in place. In some embodiments, it may be advantageous to have the ear tube placement device 1200 with a curved suction shaft 1204, as this will allow the ear tube placement device 1200 to reach different areas of the TM with a slight rotation of the suction shaft 1204.

Reference is now made to fig. 23 to 26. In one embodiment of the ear visualization/suction device 1300, an optional handle angle adjustment member 1310 can be provided. Fig. 23 shows a portion of the device 1300 without the handle angle adjustment member 1310, showing the handle 1302 with the finger ring 1306, and the main shaft 1304. Fig. 24 shows a removable handle angle adjustment member 1310 having a straight hand rest portion 1312, a curved portion 1314, and an attachment portion 1316 attached to the handle 1302. Attachment portion 1316 may be slid into place on handle 1302 such that the diameter of handle 1302 and/or a stop member along handle 1302 assists in positioning attachment portion 1316. In some embodiments, a user may move attachment portion 1316 along handle 1302 to any suitable location on handle 1302. In different embodiments, optional handle angle adjustment member 1310 may have any number of different sizes, shapes, and angles. Curved portion 1314 may have any suitable angle, for example. In some embodiments, the curvature of the curved portion 1314 may be adjusted by a user, for example, the curved portion 1314 may be malleable. In some embodiments, the device 1300 may be provided with a plurality of differently shaped handle angle adjustment members 1310, each having a different angle, shape, and/or size.

Fig. 25 shows a portion of the device 1300 that a user holds without the handle angle adjustment member 1310. This figure shows a first relative angle between the user's hand and the handle 1302, and a first orientation of the primary axis 1304 of the apparatus 1300 relative to the hand. Fig. 26 shows the same user holding a device 1300 with a handle angle adjustment member 1310 attached. As seen here, the handle 1302 is now tilted in a more upward direction relative to the user's hand, and the main axis 1304 of the device 1300 is tilted toward the hand at a greater angle than in fig. 24. At the same time, however, the overall position of the user's hand is almost exactly the same in fig. 25 and 26. This shows that the handle angle adjustment member 1310 (or an alternative embodiment thereof) can help the user to access and visualize different parts of the ear without having to assume an awkward or uncomfortable hand position.

Fig. 27A and 27B are schematic diagrams of an embodiment of a combined ear visualization/suction device 1400 showing an orientation when the combined ear visualization/suction device 1400 is inserted in the right ear (fig. 27A) and in the left ear (fig. 27B) while being held by the left hand. These two figures are a simple illustration of the device 1400 to show how the working area is defined in the ear canal in some cases. For example, fig. 27B shows a representation of a region of interest in the left ear canal LEC and the left ear LE. "region of interest" may refer to a region in the ear and/or one or more structures in the ear, such as, but not limited to: the tympanic membrane, an area of the middle ear just beyond the tympanic membrane, an area just before the tympanic membrane, or any other suitable area and/or structure in the ear. The device 1400 is held in the user's left hand (hand not shown) and the viewing angle is represented in the figure by an eye symbol at the distal tip 1412 of the device 1400. Device 1400 includes a proximal bend 1410, which proximal bend 1410 allows for a working area 1420 within the left ear canal LEC. The working area 1420 can be passed by one or more tools for performing a surgical procedure on the left ear LE area of interest. As shown in fig. 27B, when the user holds the device 1400 in his left hand and uses the device 1400 to access the left ear canal LEC, the working area 1420 is sufficient for passage of one or more tools because the working area 1420 has a relatively large access opening (opening from outside the patient into the ear canal).

In contrast, referring to fig. 27A, when a left-handed user uses the apparatus 1400 to enter the right ear canal REC to view a region of interest in the right ear RE, this embodiment of the apparatus 1400 may intercept the access opening of the working area 1414, which may make it more difficult for the user to insert a working tool into the ear canal REC. Although the overall size of working area 1414 in fig. 27A is approximately the same as the size of working area 1420 in fig. 27B, the configuration of working area 1414 in right ear canal REC may be problematic for a left-handed user for tool passage. This may require the user to position his/her hand in an awkward position or to insert a tool through the ear canal REC in an awkward manner. The same problem may occur if a person holds the device 1400 with the right hand and uses the device 1400 in the left ear canal LEC.

Fig. 28A and 28B are schematic views of an alternative embodiment of a combined ear visualization/suction device 1500, showing orientations when the combined ear visualization/suction device 1500 is inserted in the right ear (fig. 28A) and in the left ear (fig. 28B) while being held by the left hand. In this embodiment, the device 1500 includes a proximal bend 1510 and a distal bend 1520, the distal bend 1520 being closer to the distal end 1522 of the device 1500. Thus, when the device 1500 is held by the left hand of a user and inserted into the right ear canal REC, the working area 1524 is formed with an opening and overall width large enough to allow passage of a tool. Distal bend 1520 may be formed in any of a variety of ways, and may be fixed or adjustable in different embodiments. For example, in some embodiments, the distal portion of the device 1500 may be malleable so that a user can form and adjust the distal bend 1520. In other embodiments, the distal bend 1520 or distal portion of the device 1500 can be rotatable. Alternatively, the field of view of the camera at the distal end 1522 of the apparatus 1500 may be rotated or otherwise adjusted, such as by electronic adjustment, to allow a desired viewing angle to be obtained.

Fig. 28B shows a device 1500 having a distal bend 1520, the distal bend 1520 adjusted to have a different angle, designed to enter the left ear canal FEC and view the left ear region of interest FE. In this case, the working area 1530 is also wide enough to allow the passage of tools. Different alternative embodiments may have any number, location, and angle of bends. In one embodiment, a left-handed device and a right-handed device may be provided.

The above description of various apparatus and method embodiments and features is considered complete. However, these embodiments are exemplary in nature and not exhaustive. Therefore, their description should not be construed as limiting the scope of the invention.

Claims

1. An apparatus for visualizing and providing suction for a surgical procedure in an ear, the apparatus comprising:

a handle;

a spindle extending from the handle and defining a longitudinal axis;

an imaging sensor at a distal end of the spindle;

a light source at the distal end of the spindle;

a suction shaft extending from the handle and parallel to the longitudinal axis of the main shaft; and

a spring coupled with at least one of the suction shaft or the handle such that when the suction shaft is advanced in a distal direction and then released, the suction shaft automatically retracts.

2. The device of claim 1, further comprising a thumb press member coupled with the proximal end of the suction shaft, wherein the spring is disposed on the proximal portion of the suction shaft between the top of the handle and the bottom of the thumb press member.

3. The apparatus of claim 1, wherein the suction shaft comprises:

a straight proximal portion extending parallel to the longitudinal axis of the main shaft; and

a curved distal portion, wherein the suction shaft is coupled with the handle such that the suction shaft can rotate and thereby direct the curved distal portion in different directions.

4. The device of claim 3, further comprising a thumb press member coupled with the proximal end of the aspiration shaft.

5. The device of claim 4, further comprising surface features on a top surface of the thumb pressing member for assisting a user in rotating the thumb pressing member to rotate the suction shaft.

6. The apparatus of claim 5, further comprising:

a handle suction port on the handle;

a freely rotating suction member disposed on a proximal portion of the suction shaft such that the freely rotating suction member does not rotate when the suction shaft rotates;

a suction shaft suction port on the freely rotating suction member; and

a suction tube connecting the handle suction port with the suction shaft suction port.

7. The device of claim 6, wherein the freely rotating suction member houses two O-rings positioned above and below a hole in the suction shaft that communicates with the suction shaft suction port on the freely rotating suction member, and wherein the O-rings and the freely rotating suction member form a seal with the suction shaft on the hole.

8. The device of claim 1, wherein the suction shaft has an outer diameter of no greater than 1.1 millimeters.

9. The device of claim 1, further comprising a suction shaft guide positioned on one side of the main shaft, wherein the suction shaft extends through the suction shaft guide.

10. The apparatus of claim 1, further comprising:

a first suction shaft guide positioned on a first side of the main shaft; and

a second suction shaft guide positioned on a second side of the main shaft,

wherein the suction shaft is passable through the first or second suction shaft guides to provide suction on either side of the main shaft.

11. The device of claim 1, wherein the suction shaft comprises a sharp distal tip for piercing the tympanic membrane, and wherein the device further comprises a stop member on the suction shaft for preventing an ear tube positioned on the suction shaft from sliding proximally along the suction shaft past the stop member.

12. The device of claim 1, wherein the handle is adjustable from a straight configuration to an angled configuration.

13. The device of claim 1, further comprising a handle angle adjustment member removably attached to the handle to adjust an angle at which a user holds the handle.

14. The apparatus of claim 1, wherein the suction shaft extends alongside the main shaft.

15. The device of claim 1, wherein the suction shaft extends through the main shaft.

16. The device of claim 1, wherein the handle comprises at least one suction tube port for attaching a suction tube between the handle and the suction shaft.

17. The device of claim 16, wherein the handle further comprises at least one suction finger control port configured to allow a user to control the application of suction by placing a finger on the finger control port and releasing the finger from the finger control port.

18. The device of claim 1, wherein the handle comprises a finger loop configured to allow the device to be held by a single finger of a user.

19. The device of claim 18, wherein the finger ring is configured to extend around a middle finger of the user's hand, wherein the device further comprises a thumb-pressing member to be manipulated by a thumb of the same hand, and wherein the handle further comprises a suction control port configured to be covered by an index finger of the same hand.